Concomitant Tracheostomy and Lung Resection | NCT01053624

Studies
Concomitant Tracheostomy and Lung Resection

NCT01053624

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Jan 19, 2011Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Lung Cancer

Interventions

Tracheostomy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Jun 2010Estimated

Completion Date

Jun 2010Estimated

First Submitted Date

Jan 5, 2010

First Submission Date that Met QC Criteria

Jan 20, 2010

First Posted Date

Jan 21, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2011

Last Update Posted Date

Jan 19, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University Hospital, Clermont-FerrandOTHER

Collaborators

Not provided

Description Module

Brief Summary

This protocol has been designed to determine if tracheostomy performed immediately after lung operation (i.e. concomitant tracheotomy) could improve the postoperative outcome of high risk patients. We hypothesized that concomitant tracheotomy could reduce the length of mechanical ventilation and the number of respiratory complications.

Detailed Description

Background: Respiratory failure after lung resection is a major complication. Several studies suggest that low predictive postoperative pulmonary function is a predictive factor of mechanical ventilation (MV). In critically ill patients requiring MV, early tracheostomy may shorten the duration of MV and length of stay in intensive care.

Study objective: To determine whether concomitant tracheostomy (CT) would decrease the length of MV and improves outcome in patient with predictive postoperative forced expiratory volume in 1 second (FEV1ppo) < 50%. We call CT a tracheostomy performed immediately after the lung resection under the same general anesthesia.

Method: An open monocentric randomized controlled trial has been design. Inclusion and exclusion criteria are mentioned below. FEV1ppo will be calculated by the mean of the scintigraphic method for pneumonectomy and by the mean of the number of resected segments for lobectomy and segmentectomy. Randomization will be made the day before the operation. The procedure will be an open surgical tracheostomy. A daily data base will be completed from randomization until discharge. The primary and secondary criteria are mentioned below.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tracheostomy	Procedure	This protocol has been design to determine if tracheostomy performed immediately after lung operation (i.e. concomitant tracheotomy) could improve the postoperative outcome of high risk patients. We hypothesized that concomitant tracheotomy could reduce the length of mechanical ventilation and the number of respiratory complications

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of mechanical ventilation days after operation until discharge		2 months

Secondary Outcomes

Measure	Description	Time Frame
60 days mortality rate		2 months
ICU length of stay		2 months
hospital length of stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 18 and 79 years old
preoperative diagnosis of suspected lung cancer
patient considered operable according to the guidelines
30% < postoperative predicted FEV1 < 50%
informed consent obtained by patient

Exclusion Criteria:

- age less than 18 and more than 79
pregnant woman
preoperative tracheostomy
postoperative vocal cord paralysis
postoperative diaphragmatic paralysis (except for pneumonectomy)
neuromuscular disorders
previous pharyngeal or laryngeal surgery
anatomical deformity of the neck making risky a tracheostomy
consent refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick Lacarin	Contact	04 73 75 11 95		placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Marc Filaire, MD	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand	Recruiting	Clermont-Ferrand		63003	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26730752	Derived	Filaire M, Tardy MM, Richard R, Naamee A, Chadeyras JB, Da Costa V, Bailly P, Eisenmann N, Pereira B, Merle P, Galvaing G. Prophylactic tracheotomy and lung cancer resection in patient with low predictive pulmonary function: a randomized clinical trials. Chin Clin Oncol. 2015 Dec;4(4):40. doi: 10.3978/j.issn.2304-3865.2015.11.05.

ID	Term
D008175	Lung Neoplasms
D011183	Postoperative Complications
D012131	Respiratory Insufficiency

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D058109	Airway Management
D013812	Therapeutics
D010030	Ostomy
D013514	Surgical Procedures, Operative